Biocompatibility testing for medical devices
…and over 1000 other happy clients
Broad selection of ISO 10993 testing services
Measurlabs offers most tests within the ISO 10993 standard family. For new medical devices, at least the following four core tests are typically required for market approval:
We also offer additional analyses for evaluating further biological effects, such as hemocompatibility (ISO 10993-4), pyrogenicity (ISO 10993-11), and genotoxicity (ISO 10993-3). Both in vitro and in vivo methods are available for many of these assessments.
The appropriate testing strategy is always decided on a case-by-case basis, based on the device's composition, intended use, and associated risks. The recommended way to start is to create a Biological Evaluation Plan (BEP), which evaluates these risks in a structured manner and outlines the tests required to assess them. We can help prepare the BEP, as well as the Biological Evaluation Report (BER) to summarize the results.
Do not hesitate to contact us for more information or a quote for your device. You can also book a free 30-minute biocompatibility kick-off meeting to discuss your testing needs with our experts in more detail.
Questions?
Elina Tenhunen and our other Medical Device Testing Experts are happy to help.
Beyond biocompatibility: full suite of medical device testing services
In addition to ISO 10993 biocompatibility assessments, Measurlabs' service selection includes medical device packaging validation, bacterial endotoxin testing, cleaning validation, bioburden and sterility evaluations, and mechanical testing.
The tests are performed in our ISO 17025-accredited and GLP-certified partner laboratories. This ensures that you get the test reports in a format suitable for EU MDR conformity assessments and US FDA premarket submissions.
Our experts will support you throughout the process. With their help, you can reduce the time spent on navigating regulatory requirements and method selection, freeing valuable resources for other important projects and tasks.
Why choose Measurlabs?
Widest range of testing methods – get all your tests done in the same place.
Best laboratories – for every test, we have sourced the best lab for that particular method, which means that you get the most accurate results and the best price.
Personal service – get help from method experts if you are unsure about standards, your testing needs or sample suitability.
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Have questions or need help? Email us at info@measurlabs.com or call our sales team.